Cisapride Monohydrate CAS: 81098-60-4

ANALYSIS

SPECIFICATIONS

RESULTS

Assay(on dried basia)

Not less than 99.0-101.0% of C₂₃H₂₉CIFN₃O_4,caculated on anhydrous basis

99.3%

Appearance

White or alomost white crystalline powder

Almost white crystalline powder

Identification(IR)

The spectrum of sample consists with that of the reference substance

Conforms 

Related Substances

Any impurity

0.5%(max)

0.05%(RRT0.6)

0.09%(RRT1.09)

Sum of  impurities

1.0%(max)

0.20%

Residual solvents

Methanol

0.03%(max)

0.0077%

Toluene

0.089%(max)

N.D

Chloroform

0.006%(max)

N.D

Specific Rotation

Between -10°and +10°,measured at 20°.

Conforms

Residue on ignition

0.1%(max)

0.03%

Water

Between 3.4% and 4.0%

3.7%

Storage

Preserve in well-closed,light-resistant containers,and store at room temperature

Shelf Life

36 months